Status:
COMPLETED
Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone Agonist Therapy for Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and responds to insulin...
Detailed Description
* The study will be divided into 2 groups: one group (Cohort A) will consist of men undergoing GnRH agonist therapy for at least 24 months. The second group (Cohort B) will consist of men undergoing t...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate, clinical stage M0
- Scheduled to initiate GnRH agonist therapy with intended treatment duration of greater than 24 months (Group A)
- Scheduled for radiation therapy and neoadjuvant GnRH agonist therapy with intended 6 month duration of treatment (Group B)
- Karnofsky Performance Status 90 or 100
- Local or local-regional disease (Group B)
Exclusion
- Prior hormone therapy (GnRH agonist or antiandrogen)
- History of bilateral orchiectomy
- Known diabetes mellitus or glucose intolerance
- Current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00456144
Start Date
August 1 2006
End Date
September 1 2012
Last Update
July 11 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215